Autoclavable packaged compositions



United States Patent 3,113,675 AUTQCLAVABLE PACKAGEE Ctlllt ilflSi'iifiNS Perttu V. idealist, Barrington, Elk, assignor to The Kendall Company, Boston, Mass, a corporation of Massachusetts No Drawing. Filed dune 2& 1962, Ser. No. 206,203 14 Claims. (Cl. 206-84) This invention relates to packaged surgical glove lubricants and is particularly concerned with sealed packages containing dusting powder and a liquid carrier therefor, wherein the liquid is characterized by a relatively high boiling point and low heat of vaporization.

A surgical operating team is ordinarily composed of sterile members and non-sterile members. Sterile surgical gloves are worn by all members of an operating room team coming into contact with the patient or any of the sterile items or implements which contact the patient during an operation. Surgical gloves are ordinarily made of rubber and are intended to fit skin tight. Dusting powders are employed as a glove lubricant to facilitate putting on the glove. The dusting powders, obviously, must be sterile. conventionally, the dry lubricating dusting powders are sterilized in the hospital operating room autoclave along with the caps, gowns, gloves and implements employed in an operation. The sterile packages of the dry dusting powders are handled by the sterile mem bers of the operating team. Usually, the packages are opened by a sterile assistant and the powder applied to the hands by a rubbing motion. If the package is handled and opened by a non-sterile assistant, the package must be opened in such manner that the sterile contents do not contact the non-sterile assistant. Even when great care is exercised, a dust cloud of finely ground powder is difiicult to avoid when the hands are rubbed together to apply the powder. Fine grains of the powder also escape into the air while stretching and form-fitting the gloves to the hands. The formation of the dust clouds and the escape of dry powder to the air is sometimes called flyaround. Ply-around is undesirable since the dust particles may eventually settle into the wound or the cavity being operated on. As has been recognized in recent years, dusting powders from fly-around can cause postoperative complications. These complications can be the result of the type of dusting powder employed, as in the case of talc, or the result of infection from fly-around particles which have become non-sterile by contact with, for example, a non-sterile circulating assistant and then settling into the cavity or wound.

Recently, dusting powders in the form of lotions or creams have been offered as a substitute for the dry powders. These lotions or creams usually consist simply of a suitable medical dusting powder and a low boiling point, volatile alcohol, such as ethyl alcohol. Fly-around can be eliminated during application of the lotion or cream to the hands. After evaporation of the ethyl alcohol, manipulation and flexing of the hands should be kept at a minimum to prevent flake-off and fly-around. These lotions or creams must be supplied to the hospital presterilized since it would be impractical to package these products in containers which would withstand the pressure of ethyl alcohol in an autoclaving operation. The presterilized alcohol/ dusting powder mixture is packaged in a double envelope package. This package consists of an inner envelope containing the mixture of the alcohol and dusting powder. The sealed inner envelope is encased in an outer sealed envelope. The contents of the inner envelope, the outside surface of the inner envelope and the inside surface of the outer envelope are sterilized in accordance with known techniques which do not require the use of high temperatures, thereby avoiding explosion of the package due to volatilization of the ethyl alcohol component.

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The outer envelope must not be handled by the sterile members of the operating team. The use of these presterilized dusting powder lotions or creams requires the use of an assistant. The assistant opens the outer envelope in a manner so as to not come into contact with the inner envelope. The sterile inner envelope is then taken either by the user of the dusting powder or a sterile assistant. The inner envelope is opened and the sterile contents applied to the hands. As can be seen, the use of these products requires special handling procedures diiferent from conventional operating room procedures.

Both the outer and inner envelopes of these packages must be permanently sealed. Either a poor seal or rup ture of the seal during handling of the double envelope packages from the supplier to the operating room renders these lotions or creams unsuitable for use. There is always the risk that the product becomes non-ster-ile through minute openings in the envelopes, not readily apparent to visual inspection. The use of presterilized dusting powders, therefore, involves an element of risk.

An object of this invention is a sealed package containing a dusting powder in lotion or cream form which can be sterilized in accordance with conventional operating room autoclaving techniques. An object of this inve tion is a steam sterilizable sealed package containing a dusting powder in lotion or cream form which can be sterilized in the operating room. An object of this invention is elimination of the risk inherent in the double envelope packaged forms of presterilized dusting powders, lotions or creams. A particular object of this invention is a steam sterilizable package containing a surgical glove lubricant and a liquid carrier therefor which does not require special handling attention in la surgical operating room routine. Included among the objects of this invention is an autoclavable sealed package of a glove dusting powder lotion or cream containing an ingredient which helps to retain the powder upon the hands. Another objeot of this invention is improved reduction or elimination of fly-around during manipulation of the hands in the act of applying the surgical rubber gloves thereon.

in accordance with this invention, a dusting powder and a liquid having the proper combination of boiling point and heat of vaporization are mixed in appropriate proportions to a suitable consistency for spreading on the hands. The dusting powder may be any of the commercially available medical dusting powders which aid in slipping the hands into rubber or plastic gloves. Starch dusting powders, and particularly starch modified to render it absorbab-le by body tissues, are preferred. Starches from any source may be employed and include corn starch, wheat starch, potato starch, tapioca starch, waxy maize starch, sago starch, and the like. Tialc may also be employed as the dusting powder, although the use of talc has fallen into some disuse because of post-operative complications traced to talc used in surgeons gloves. To the extent that fiy-around can be reduced or eliminated in accordance with formulations of this invention, the use of talc or flow improving agents for starch may be employed with an increased degree of safety.

The foregoing principal and other objects of this invention are accomplished by employing a liquid carrier for the dusting powder, which liquid has a boiling point above the temperature of steam at the pressure of an autoclaving operation and, also, a low heat of vaporization. Surprisingly, organic liquids having a relatively high boiling point within the range of about 240 F. to about 385 F., preferably within the range of about 240 F. to about 310 F., and which also have a heat of vaporization no greater than 200 calories per gram at atmospheric pressure readily and rapidly evaporate from the skin. The liquid component of these lotions or creams substantially evaporates during the act of spreading the product on the 3 hands as by a gentle rubbing motion. Generally, surgeons preference requires that the liquid must evaporate with a feeling of substantial dryness within a period of about 45 seconds after application to the hands. In accordance with this invention, the liquid component of the lotions or creams evaporates Within a period of about to 45' seconds from a thin coating thereof spread upon the hands.

In addition to the essential combination of high boiling point and low heat of vaporization, the liquids must also be non-toxic and non-irritating to the skin. The liquids must be non-toxic and non-irritating in terms of toxicity and irritation in the relatively short time of contact with the skin during application of the lotion to the hands. An excellent liquid suitable for use in the formulations of this invention and having non-toxic and non-irritating characteristics comparable to the highly volatile ethyl alcohol is 1-methoxy-2-propanol. This liquid has a boiling point slightly greater than 248 F. and a heat of vaporization of 102 calories per gram at atmospheric pressure. The boiling point of this liquid is well above the temperature of the saturated steam at the pressures employed in conventional autoclaving operations in surgical operating rooms. Conventional surgical sterilizing operations employ steam at temperatures Within the range of 240 F. to 250 F. and corresponding pressures within the range of 10 to pounds per square inch gauge. Under these conditions, the steam temperature is well below the boiling point of the l-methoxy-Z-propanol. The pressure of the l-methoxy-Z-propanol during the autoclaving operation is sufliciently low that special strong-walled packages need not be employed. Packages which can be easily opened as by tearing may be used. The package material must, of course, be practically impermeable to vapors and gas.

The mixture of dusting powder and l-methoxy-Z-propanel may be conveniently packaged in aluminum foil packages, plastic foil packages in which the packages may take any shape, including tubular for-ms thereof. The packages, of course, are hermetically sealed.

An example of a packaged dusting powder cream which can be sterilized in accordance with conventional autoclaving procedures is a mixture of 10 parts of corn starch and 10 parts of l-methoxy-Z-propanol, on a. weight basis. These components were mixed until a homogeneous creamy suspension was obtained. The suspension was packaged in :a polyethylene film envelope. The edges of the polyethylene panels of the envelope were hermetical- 1y sealed under elevated temperature and pressure. The packaged cream iwas sterilized in an autoclave at a saturated steam temperature of 240 F. under a pressure of about 10 pounds per square inch for a period of 29 minutes. At the end of this period as in the case of a sterilization cycle for the garments worn in an operating room, the steam was removed from the autoclave chamber under a slow exhaust. A slight vacuum was drawn to assure removal of moisture. The contents of the package and the outside surface of the package were sterile. The package could be handled by the surgeon without contamination. The package may be opened by either tearing or cutting :the package. The cream was squeezed from the package onto the hands and the cream spread upon the ands by a rubbing motion. The l-methoxy-Z- propanol evaporated at ordinary room temperature within a period of about to seconds, leaving a thin coating of dried lubricating starch powder on the skin.

Other ether liquids are those short chain alkyl others of ethylene glycol, propylene glycol, diethylene glycol and dipropylene glycol having the critical relationship between boiling point and heat of vaporization specified above. The short chain alkyl group may contain from 1 to 4 carbon atoms. Specific examples within this class are mcthoxy ethanol, which has a boiling point of 256.2 F. and a heat of vaporization of 123.9' calories per gram; l-ethoxy ethanol having a boiling point of 275 F. and a heat of vaporization of 107.5 calories per gram; ethylene glycol n-butyl ether having a boiling point of 339.8 F. and a heat of vaporization of 88.4 calories per gram; dipropylene glycol methyl ether having a boiling point of 370.4 F. and a heat of vaporization of 73.1 calories per gram; and diethylene glycol methyl ether having a boiling point of 381.2 F. and a heat of vaporization of 92.7 calories per gram. The alkyl others of the glycols which do not have a combination of boiling point and heat of vaporization within the aforestated range are, of course, excluded from this class. The short chain alkyl ethers of ethylene glycol and propylene glycol having a boiling point within the range of 240 F. to about 310 F. and heats of vaporization below 200 calories per gram are preferred. The methyl ether of diethy-lene glycol is not sufficiently volatile to satisfy the preferences of most surgeons.

The liquid components of the packaged lotions or creams of this invention are not restricted to liquid ethers. Examples of other liquids suitable for the purposes of this invention but .found objectionable by some on grounds of odor are perchloroethylene having a boiling point of 249.8 F. and a heat of vaporization of 51 calories per gram; ethylene bromide having a boiling point of 266 F. and a heat of vaporization of 46 calories per gram; and diethyl carbonate having a boiling point of 258.8 F. and a heat of vaporization of 73 calories per gram. Another class of liquids for use in accordance with this invention are fiuorinated aliphatic hydrocarbons such as pcrfiuorop-ropylcyclohexane, perfiuoroiisoproplycyclohexane, perfiuorotrimethylcyclohexane and perfiu'orononene- 1. Other suitable liquids having the necessary properties will be readily apparent to those skilled in the art. It is within the skill of the art to judicially select suitable liquids in accordance 'with the principles set forth herein.

If desired, chemical sterilizing agents may be incorporated in the package as a precautionary measure to insure sterilization of the contents of the package. For example, a small amount of ethylene oxide may be added to the inside of the package with the lotion or cream. Ex perience has shown that the ethylene oxide need not exceed about 4%, by weight, of the lotion or cream formulation.

The above suspension may be somewhat unstable, the liquid and starch dusting powder separating upon standing. This may be corrected by shaking the sealed package either prior to or after sterilization. The stability of the suspension may be improved by the addition of minor amounts of suspending agents or gel-forming compounds. Certain cellulose ethers function as suspending agents and gel formers. These cellulose others also advantageously improve the spreadability of the lotion or cream and help to retain the dried powder upon the skin, thereby reducing or eliminating fiy-around. Cellulose ethers suitable for these purposes are methylcellulose, hydroxypropyl methylcellulose and mixtures thereof. The methylcellulose is essentially a diinethyl ether of cellulose containing from about 26% to about 33% me-thoxy groups on a weight basis, corresponding to amethoxy degree of substitution (D.S.) of 1.6 to about 2.03. The hydroxypropyl methylcellulose others have a varying ratio of propylene glycol ether substitution to methoxy substitution. The methoxy substituent is the major substituent, comprising 84% to 93% of the groups attached to the cellulosic unit. Only a very minor amount of the cellulose ethers need be employed in the lotions or creams. Ordinarily, 1% by Weight of the cellulose ether, based on the weight of the liquid, will suffice. Preferably, not more than about 5% by Weight of the cellulose ether should be employed. 1

An example of a creamy suspension of improved stability is as follows.

Ingredients: Parts by weight l-methoxy-Zpropanol 500 Hydroxypropyl methylcellulose 5 Starch 340 Compounding of this lotion is achieved by refluxing and stirring the 1-methoXy-2-propanol and the hydroxypropyl methylcellulose ether for 45 to 60 minutes. The gelled solution was cooled to 100 F. The starch was added while stirring the gel. The mixture was then permitted to cool to room temperature and approximately of liquid ethylene oxide was added with stirring. This mixture was added to a packet made from a laminate of 1 mil aluminum foil and 1 /2 mils polyethylene. The polyethylene laminae faced into the package. The packet was approximately 1 /2 by 3% in size. Approximately 3 grams of this formulation was added to the packet and the packet was hermetically sealed.

The hermetically sealed packet was autoclaved for 40 minutes at a saturated steam temperature of 250 F. and

under a pressure of 15 pounds per square inch. The steam was slowly exhausted from the chamber and a slight vacuum drawn. Autoclaving conditions at temperatures ranging from 240 F. to 250 F. at from to pounds per square inch pressure and subsequent slow exhaust simulate those conditions employed in conventional hospital au-toclaving procedures. The vapor pressures of the contents in the packet were insuficient to burst or rupture the packet. After removal from the autoclave the packet could be handled directly by the surgeon or any other sterile member of the operating team, in accordance with conventional practice as in the case of sterile dry powders.

Upon opening the packet, no separation of starch and liquid was noted. The suspension spread well on the hands and dried in approximately seconds. After d1 ing, the coated hands could be manipulated and flexed rather freely without notice of any dust cloud formation.

The proportions of the dusting powder and liquid may vary widely, depending upon Whether a liquid, creamy, or pasty type formulation is preferred. If too little of the liquid is employed, the suspension is rather stiff and difiicul-t to apply evenly. An excessive amount of liquid is not desired for the reason that the suspension will run freely from the hands or open packet. Generally, the amount of the liquid may vary from between and 200 parts by weight per 100 par-ts by weight of the dusting powder. A highly desirable consistency is obtained with a weight ratio of 121.67 powder and liquid.

Other miscellaneous ingredients may be added to the formulations. These include, for example, emollients, anti-perspirants, disinfiactants, and anti-microbial agents including anti-bacterial and anti-fungal compounds.

The packages are most conveniently sterilized in the load with the gloves, caps and gowns. Sterilized garments in a dry state ready for use are obtained by slowly exhausting the autoclave chamber at the end of the sterilization cycle. The step of venting the steam from the chamber for this purpose ordinarily takes from about 10 to 15 minutes. The packages must be made from materials which will withstand the conditions of the autoclaving cycle. Packages made from laminates of aluminum foil and low density polyethylene have remained hermetically sealed when exposed to a cycle of steam temperatures of 240 F. to 250 F. at pressures of from about 10 to 15 pounds per square inch gauge for periods up to '40 minutes followed by a slow exhaust of from 10 to 15 minutes. Plastic laminae having a higher softening point, such as high density polyethylene and stereo-regular polypropylenes, should be substituted for the low density polyethylene in metal foil-plastic film laminate packages when the packages are to be subjected to higher temperatures and rapid exhaust steps in the autoclaving operation.

As various embodiments could be made in the invention described herein and since many different changes can be made in the embodiments set forth, it is to be understood that all material disclosed is to be interpreted as illustrative and not in a limiting sense.

What is claimed is: 1. An autoclavable sealed package containing a surgical glove lubricant in admixture with an organic liquid, said liquid having a boiling point above the temperature of steam at the pressure of an autoclaving operation and a low heat of vaporization whereby said liquid evaporates in about 10 to 45 seconds from a thin coating of the lubricant and liquid spread upon the hands by rubbing the mixture thereon.

2. An autoclavable sealed package containing a medical dusting powder in admixture with an organic liquid, said liquid having a boiling point above the temperature of steam at the pressure of an autoclaving operation and a low heat of vaporization whereby said liquid evaporates in about 10 to 45 seconds in a thin coating of the powder and liquid spread upon the hands by rubbing the mixture thereon.

3. An autoclavable sealed package containing a surgical glove lubricating powder and an organic liquid, said liquid having a boiling point above the temperature of steam at the pressure of an autoclaving operation and a heat of vaporization no greater than about 200 calories per gram at atmospheric pressure.

4. An autoclavable sealed package containing a surgical glove lubricating powder and an organic liquid, said liquid having a boiling point within the range of about 240 F. to about 385 F. at atmospheric pressure and above the temperature of steam at the pressure of the autoclaving operation, and a heat of vaporization no greater than about 200 calories per gram at atmospheric pressure.

5. An autoclavable sealed package containing a surgical glove lubricating powder and an organic liquid, said liquid having a boiling point within the range of about 240 F. to about 310 F. at atmospheric pressure and above the temperature of steam at the pressure of the autoclaving operation, and a heat of vaporization no greater than 200 calories per gram at atmospheric pressure.

6. An autoclavable sealed package containing a surgical glove lubricating starch powder and an organic liquid having a boiling point within the range of about 240 F. to about 310 F. at atmospheric pressure and above the temperature of steam at the pressure of an autoclaving operation, and a heat of vaporization no greater than 200 calories per gram at atmospheric pressure.

7. An autoclavable sealed package containing a surgical glove lubricating talc powder and an organic liquid, said liquid having a boiling point within the range of about 240 F. to about 310 F. at atmospheric pressure and above the temperature of steam at the pressure of an autoclaving operation, and a heat of vaporization no greater than 200 calories per gram at atmospheric pressure.

8. An autoclavable sealed package containing a surgical glove lubricating starch powder and an organic liquid, said liquid having a boiling point within the range of about 240 F. to about 385 F. at atmospheric pressure and above the temperature of steam at the pressure of an autoclaving operation, a heat of vaporization no greater than 200 calories per gram at atmospheric pressure, and selected from ethers consisting of short chain alkyl ethers of ethylene glycol, propylene glycol, diethylene glycol, dipropylene glycol and mixtures thereof, the alkyl chain containing from 1 to 4 carbon atoms.

9. An autoclavable sealed package containin a surgical glove lubricating powder and l-methoxy-Z-propanol.

10. An autoclavable sealed package containing a surgical glove lubricating starch powder, a cellulose ether selected from the group consisting of methyl cellulose, hydroxypropyl methylcellulose and mixtures thereof, and an organic liquid having a boiling point within the range of about 240 F. to about 310 F. at atmospheric pressure and above the temperature of steam at the pressure of an autoclaving operation, and a heat of vaporization no greater than about 200 calories per gram at atmospheric pressure.

11. An autoclavable sealed package containing a surgical glove lubricating starch powder and a cellulose other selected from the group consisting of methylcellulose, hydroxypropyl methylcellulose and mixtures thereof, and an organic liquid, said liquid having a boiling point within the range of about240 F. to about 385 F. at atmospheric pressure and above the temperature of steam at the pressure of an autoclaving operation, a heat of vaporization no greater than 200 calories per gram at room temperature, and selected from ethers consisting of short chain alkyl others of etlwlene glycol, propylene glycol, cliethylene glycol, dipropylene glycol and mixtures thereof, the alkyl chain containing from 1 to 4 carbon atoms.

12. An autoclavable sealed package containing a surgical glove lubricating starch powder and an organic liquid in the proportions of from about St) to 200 parts by weight per 100 parts by weight of said powder, said liquid havin' a boiling point within the range of about 240 F. to about 310 F. at atmospheric pressure and above the temperature of steam at the pressure of an autoclaving operation, and a heat of vaporization no greater than 200 calories per gram at atmospheric pressure.

13. An autoclavable sealed package containing a surgical glove lubricating starch powder and an organic liquid in the proportions of from about 50 to 200 parts by Weight per 100 parts by weight of said powder, said liquid having a boiling point within the range of about 240 F. to about 385 F. at atmospheric pressure and above the temperature of steam in the pressure of an autoclaving operation, a heat of vaporization no greater than 200 calories per gram at atmospheric pressure, and selected from ethers consisting of short chain alkyl ethers of ethylene glycol, propylene glycol, diethylene glycol, dipropylene glycol and mixtures thereof, the alkyl chain containing from 1 to 4 carbon atoms.

14. An autoclavable sealed package containing a surgical glove lubricating starch powder, a cellulose other selected from the group consisting of methylcellulose, hydroxypropyl methylcellulose and mixtures thereof, and an organic liquid having a boiling point within the range of about 240 F. to about 385 F. at atmospheric pressure and above the temperature of steam at the pressure of an autoclaving operation, a heat of vaporization no greater than about 200 calories per gram at atmospheric pressure and selected from ethers consisting of short chain alhyl ethers of ethylene glycol, propylene glycol, dietbyiene glycol, dipropylene glycol and mixtures thereof wherein the alkyl chain contains from 1 to 4 carbon atoms, the proportion of said liquid being from 50 to about 200 parts by weight per 100 parts by weight of said powder.

References Cited in the file of this patent UNITED STATES PATENTS 1,936,845 Lautmann Nov. 28, 1933 1,953,686 Natwick Apr. 3, 1934 2,469,957 Fenn May 10, 1949 2,626,257 Caldwell et a1. J an. 20, 1953 2,634,856 Perkins Apr. 14, 1953 FOREIGN PATENTS 527,053 Belgium Sept. 8, 1954 

9. AN AUTOCLAVABLE SEALED PACKAGE CONTAINING A SURGICAL GLOVE LUBRICATING POWDER AND 1-METHOXY-2-PROPANOL. 